EPA Biotech Review Staff Prepares To Handle Engineered Microorganism TSCA Submissions
(Biobased and Renewable Products Advocacy Group) On November 9, 2016, Inside EPA published “New TSCA Requirements Raise Challenges To EPA Biotech Review Staff” (subscription required), outlining what EPA has done to adapt to revised Toxic Substances Control Act (TSCA) requirements for engineered microorganisms. Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), was quoted in the article discussing what to expect from approaching biotechnology regulations:
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“I think EPA’s still figuring out what ‘reasonably foreseeable’ means. It’s a challenge for chemicals as well as microorganisms.
Noting that the Lautenberg Chemical Safety Act, which reformed TSCA, “is silent on microorganisms,” Engler adds that the “effect of Lautenberg is parallel for chemicals and microorganisms.” A key change in the updated law, Engler says, is the new requirement that EPA make an affirmative decision on whether new chemicals or microorganisms meet TSCA’s risk standard of “will not present an unreasonable risk of injury to health or the environment,” which is “true for chemicals and microorganisms.”
One difference that Engler notes is that if a newly submitted chemical “is a new microbe, it increases the data need for EPA to show not likely to present” unreasonable risk.
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As an example, Engler said that “if a [microbial commercial activity notices (MCAN)] submitter had a contained use [of a microorganism] with complete destruction of the organism but if EPA was unsure . . . they might place a SNUR on the microorganism that the submitter or anyone else would have to abide by.”
In this example, as in other cases, Engler said, EPA would treat a new organism and the decision on whether to place a SNUR on other uses of that microorganism as it would a new chemical. “It’s the same rules,” he said. “The hazards are different, there are other risks because they’re living organisms. There are concerns about gene transfer between the MCAN organism and whatever’s in the wild. But the criteria is the same and the regulatory tools they use to contain are the same.” READ MORE
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